Trial Outcomes & Findings for Response of Alkylresorcinols to Different Cereals (NCT NCT01287403)
NCT ID: NCT01287403
Last Updated: 2018-08-31
Results Overview
Area under the curve (AUC) over baseline of alkylresorcinol compounds are measured for the 6 interventional arms. Time points are: t = 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 and 48 h after product intake.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
From 0 to 48 h post dose.
Results posted on
2018-08-31
Participant Flow
14 healthy subjects were recruited within the staff of the Nestle Research Center. After being informed, by written and orally, on the aims, methods, risk/benefit ratio for the study, they signed an informed consent form and underwent a medical visit screening as per protocol
Thirteen subjects completed the trial, where 100 g of each flour, mixed with 300 mL milk, was fed to all subjects. Subjects avoided foods containing whole grains for one week prior, and 36 h before the start of each treatment, to avoid all phenolic-rich foods (e.g. coffee, tea, chocolate, most fruits and vegetables).
Participant milestones
| Measure |
Six Products (Flours) Assigned Randomly (Cross Over)
In a crossover design, all subjects were administered the 6 following products in a randomized order:
Esterase wholegrain wheat flour: a cereal flour treated with esterases to release phenolics (positive control for phenolic acids).
Refined wheat flour: a treated cereal flour mixed with milk (negative control).
Liquid whole grain wheat flour: a treated cereal flour mixed with milk.
Liquid wholegrain barley flour: a treated cereal flour mixed with milk.
Wholegrain wheat flour: a treated cereal flour mixed with milk.
Wholegrain barley flour: a treated cereal flour mixed with milk.
|
|---|---|
|
Diet Restriction (7 Days)
STARTED
|
14
|
|
Diet Restriction (7 Days)
COMPLETED
|
14
|
|
Diet Restriction (7 Days)
NOT COMPLETED
|
0
|
|
1st Intervention (1 Day)
STARTED
|
14
|
|
1st Intervention (1 Day)
COMPLETED
|
13
|
|
1st Intervention (1 Day)
NOT COMPLETED
|
1
|
|
Washout 7 Days
STARTED
|
13
|
|
Washout 7 Days
COMPLETED
|
13
|
|
Washout 7 Days
NOT COMPLETED
|
0
|
|
2nd Intervention (1 Day)
STARTED
|
13
|
|
2nd Intervention (1 Day)
COMPLETED
|
13
|
|
2nd Intervention (1 Day)
NOT COMPLETED
|
0
|
|
Washout (7 Days)
STARTED
|
13
|
|
Washout (7 Days)
COMPLETED
|
13
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
|
3rd Intervention (1 Day)
STARTED
|
13
|
|
3rd Intervention (1 Day)
COMPLETED
|
13
|
|
3rd Intervention (1 Day)
NOT COMPLETED
|
0
|
|
4th Intervention (1 Day)
STARTED
|
13
|
|
4th Intervention (1 Day)
COMPLETED
|
13
|
|
4th Intervention (1 Day)
NOT COMPLETED
|
0
|
|
5th Intervention (1 Day)
STARTED
|
13
|
|
5th Intervention (1 Day)
COMPLETED
|
13
|
|
5th Intervention (1 Day)
NOT COMPLETED
|
0
|
|
6th and Last Intervention (1 Day)
STARTED
|
13
|
|
6th and Last Intervention (1 Day)
COMPLETED
|
13
|
|
6th and Last Intervention (1 Day)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Six Products (Flours) Assigned Randomly (Cross Over)
In a crossover design, all subjects were administered the 6 following products in a randomized order:
Esterase wholegrain wheat flour: a cereal flour treated with esterases to release phenolics (positive control for phenolic acids).
Refined wheat flour: a treated cereal flour mixed with milk (negative control).
Liquid whole grain wheat flour: a treated cereal flour mixed with milk.
Liquid wholegrain barley flour: a treated cereal flour mixed with milk.
Wholegrain wheat flour: a treated cereal flour mixed with milk.
Wholegrain barley flour: a treated cereal flour mixed with milk.
|
|---|---|
|
1st Intervention (1 Day)
Adverse Event
|
1
|
Baseline Characteristics
Response of Alkylresorcinols to Different Cereals
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=14 Participants
Includes groups randomized to receive either esterase wholegrain wheat flour first or liquid wholegrain wheat flour first or liquid wholegrain barley flour first or refined wheat flour first or wholegrain wheat flour first or wholegrain barley flour first
|
|---|---|
|
Age, Customized
< 18 years
|
0 participants
n=5 Participants
|
|
Age, Customized
between 18 and 55 years
|
14 participants
n=5 Participants
|
|
Age, Customized
> 55 years
|
0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From 0 to 48 h post dose.Area under the curve (AUC) over baseline of alkylresorcinol compounds are measured for the 6 interventional arms. Time points are: t = 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 and 48 h after product intake.
Outcome measures
| Measure |
Esterase Whole Grain Wheat Flour
n=13 Participants
A cereal flour treated with esterase to release phenolics (positive control for phenolic acids).
|
Refined Wheat Flour
n=13 Participants
A treated cereal flour mixed with milk(negative control).
|
Liquid Whole Grain Wheat Flour
n=13 Participants
A treated cereal flour mixed with milk.
|
Liquid Wholegrain Barley Flour
n=13 Participants
A treated cereal flour mixed with milk.
|
Wholegrain Wheat Flour
n=13 Participants
A treated cereal flour mixed with milk.
|
Wholegrain Barley Flour
n=13 Participants
A treated cereal flour mixed with milk.
|
|---|---|---|---|---|---|---|
|
Plasma Alkylresorcinol Compounds
|
19357 nmol/L*h
Standard Deviation 7509
|
1548 nmol/L*h
Standard Deviation 698
|
17307 nmol/L*h
Standard Deviation 5914
|
5385 nmol/L*h
Standard Deviation 2642
|
17139 nmol/L*h
Standard Deviation 6386
|
5634 nmol/L*h
Standard Deviation 2478
|
SECONDARY outcome
Timeframe: From 0 to 48 hours post doseOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0-48 h post dosePhenolic acids in plasma and urine
Outcome measures
Outcome data not reported
Adverse Events
Refined Wheat Flour
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Esterase Wholegrain Wheat Flour
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Liquid Whole Grain Wheat Flour
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Liquid Wholegrain Barley Flour
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wholegrain Wheat Flour
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wholegrain Barley Flour
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Refined Wheat Flour
n=14 participants at risk
A treated cereal flour mixed with milk (negative control).
|
Esterase Wholegrain Wheat Flour
n=14 participants at risk
A cereal flour treated with esterases to release phenolics (positive control for phenolic acids)
|
Liquid Whole Grain Wheat Flour
n=14 participants at risk
A treated cereal flour mixed with milk.
|
Liquid Wholegrain Barley Flour
n=14 participants at risk
A treated cereal flour mixed with milk.
|
Wholegrain Wheat Flour
n=14 participants at risk
A treated cereal flour mixed with milk.
|
Wholegrain Barley Flour
n=14 participants at risk
A treated cereal flour mixed with milk.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • This adverse event occurred during the 1st intervention. The subject did not wish to go on with the study.
|
0.00%
0/14 • This adverse event occurred during the 1st intervention. The subject did not wish to go on with the study.
|
0.00%
0/14 • This adverse event occurred during the 1st intervention. The subject did not wish to go on with the study.
|
0.00%
0/14 • This adverse event occurred during the 1st intervention. The subject did not wish to go on with the study.
|
0.00%
0/14 • This adverse event occurred during the 1st intervention. The subject did not wish to go on with the study.
|
0.00%
0/14 • This adverse event occurred during the 1st intervention. The subject did not wish to go on with the study.
|
Additional Information
Dr Maurice Beaumont, MD, PhD
Clinical Development Unit / Metabolic Unit
Phone: +41217858054
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place